Back to resultsA Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fecal microbiota transplantation
placebo fecal microbiota transplantation
FMT with antibiotic pre-treatment (v1)
FMT with antibiotic pre-treatment (v2)
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Fecal Microbiota Transplantation
Eligibility Criteria
Inclusion Criteria:
- IBS with diarrhea
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
fecal microbiota transplantation
placebo fecal microbiota transplantation
FMT after antibiotic pretreatment v1
FMT after antibiotic pretreatment v2
Arm Description
fecal microbiota transplantation
placebo fecal microbiota transplantation
fecal microbiota transplantation after antibiotic pretreatment
fecal microbiota transplantation after antibiotic pretreatment
Outcomes
Primary Outcome Measures
stable engraftment of donor microbiota
Stable engraftment will be defined with the Jensen-Shannon Divergence (JSD) between the bacteria community measured in the donor and recipient. Engraftment scores will be defined by the ratio between the JSD in comparison between the recipient and donor and the recipient and other healthy donors not providing material for their FMT.
Secondary Outcome Measures
Full Information
NCT ID
NCT02847481
First Posted
July 12, 2016
Last Updated
December 20, 2019
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
OpenBiome
1. Study Identification
Unique Protocol Identification Number
NCT02847481
Brief Title
A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS
Official Title
A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 5, 2018 (Actual)
Study Completion Date
August 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
OpenBiome
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota transplantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Fecal Microbiota Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fecal microbiota transplantation
Arm Type
Experimental
Arm Description
fecal microbiota transplantation
Arm Title
placebo fecal microbiota transplantation
Arm Type
Placebo Comparator
Arm Description
placebo fecal microbiota transplantation
Arm Title
FMT after antibiotic pretreatment v1
Arm Type
Experimental
Arm Description
fecal microbiota transplantation after antibiotic pretreatment
Arm Title
FMT after antibiotic pretreatment v2
Arm Type
Experimental
Arm Description
fecal microbiota transplantation after antibiotic pretreatment
Intervention Type
Procedure
Intervention Name(s)
fecal microbiota transplantation
Intervention Description
fecal microbiota transplantation
Intervention Type
Drug
Intervention Name(s)
placebo fecal microbiota transplantation
Intervention Description
placebo fecal microbiota transplantation
Intervention Type
Procedure
Intervention Name(s)
FMT with antibiotic pre-treatment (v1)
Intervention Description
FMT with antibiotic pre-treatment (v1)
Intervention Type
Procedure
Intervention Name(s)
FMT with antibiotic pre-treatment (v2)
Intervention Description
FMT with antibiotic pre-treatment (v2)
Primary Outcome Measure Information:
Title
stable engraftment of donor microbiota
Description
Stable engraftment will be defined with the Jensen-Shannon Divergence (JSD) between the bacteria community measured in the donor and recipient. Engraftment scores will be defined by the ratio between the JSD in comparison between the recipient and donor and the recipient and other healthy donors not providing material for their FMT.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IBS with diarrhea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Lembo, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35014601
Citation
Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.
Results Reference
derived
Learn more about this trial
A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS
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